Initial Experience With a Novel Single-Balloon Enteroscop... | NCT02629211

Studies
Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD

NCT02629211

Sponsor

Smart Medical Systems Ltd.

Status

Unknown status

Last Update Posted

Aug 23, 2016Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease

Interventions

NaviAid™ AB

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Jan 2017Estimated

Completion Date

Feb 2017Estimated

First Submitted Date

Dec 7, 2015

First Submission Date that Met QC Criteria

Dec 9, 2015

First Posted Date

Dec 14, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2016

Last Update Posted Date

Aug 23, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.

Detailed Description

In 15%-25% of diagnosed inflammatory bowel disease (IBD) cases, disease manifestation begins before the age of 18. IBD primary includes Crohn's disease (CD) and ulcerative colitis (UC). Studies have shown that the current incidence of pediatric IBD ranges from 4-7 cases per 100,000, worldwide. Early and accurate diagnosis of IBD is important for correct prognosis, course of disease, therapeutic decisions and follow-up. Complete diagnostic work-up is key to proper diagnosis in patients.Early diagnosis of IBD and differentiation between UC and CD can be difficult in children. The major issues that face pediatric IBD today include accurate disease classification, unknown extent of disease, complete bowel visualization, inability to reach depth of findings, and biopsy retrieval for diagnostic work-up.

The NaviAid™ AB device presents a new and unique concept that helps overcome these short comings of IBD diagnosis and treatment. Through repetitive inflation and deflation of the NaviAid™ AB, the endoscope can be swiftly advanced deep into the small bowel via the proximal or distal route, allowing for complete visualization of the small bowel and easy biopsy sampling for histopathology. As a result, subsequent diagnoses can influence proper action for further treatment and therapy for the patient. Although many studies have reported on the safety and efficacy of balloon enteroscopy in adults with IBD, further investigation of the value of balloon enteroscopy in pediatric patients with known or suspected IBD is still required.

This is a single-center, non-randomized open-label study intended to evaluate the safety and efficacy of the NaviAid™ AB device during small bowel enteroscopy in children with known or suspected IBD.

Conditions Module

Conditions

Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease

Keywords

Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Single-Balloon Enteroscopy
NaviAid AB™ Device
NaviAid AB™ Procedure
AB Device
Pediatric IBD
Pediatric Enteroscopy

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NaviAid™ AB	Experimental	NaviAid™ AB device procedure	Device: NaviAid™ AB

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NaviAid™ AB	Device	NaviAid™ AB Procedure	NaviAid™ AB

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of serious adverse events	Patients will be followed up during the study period (3 hours) and once again 48-72 hours following the procedure. At both times, serious adverse events will be assessed.	Subjects will be followed up with in 72 hours following the procedure.

Secondary Outcomes

Measure	Description	Time Frame
Number of findings	Histology results will be used to assess this outcome	Up to 14 days (histology)
Procedural times		During procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients between the ages 8-18
Patients with known or suspected IBD (including Crohn's disease or ulcerative colitis).
The patient/parent of patient must understand and provide written consent for the procedure.

Exclusion Criteria:

Subjects with known coagulation disorder;
Subjects with known hernia;
Subjects with suspected stricture or stenosis;
Any patient condition deemed too risky for the study by the investigator
Subjects who are currently enrolled in another clinical investigation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Efrat Broide	Contact	08-9779722		efibroide@yahoo.com

Overall Officials

Name	Affiliation	Role
Efrat Broide	Assaf-Harofeh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center	Recruiting	Tzrifin			Israel

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32187142	Derived	Broide E, Shalem T, Richter V, Matalon S, Shirin H. The Safety and Feasibility of a New Through-the-scope Balloon-assisted Enteroscopy in Children. J Pediatr Gastroenterol Nutr. 2020 Jul;71(1):e6-e11. doi: 10.1097/MPG.0000000000002706.

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D007410	Intestinal Diseases

ID	Term
D015212	Inflammatory Bowel Diseases
D003093	Colitis, Ulcerative
D003424	Crohn Disease